How chemotherapy given before surgery affects thinking and memory in ovarian cancer
Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer
This study will test whether chemotherapy given before surgery affects thinking and memory in people with newly diagnosed advanced epithelial ovarian cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT07125209 on ClinicalTrials.gov |
What this trial studies
This observational study will follow 18 people with newly diagnosed advanced epithelial ovarian cancer who are planned to receive neoadjuvant chemotherapy. Participants will complete patient-reported outcomes (FACT-O and FACT-Cog) and objective cognitive tests at baseline, after three cycles of neoadjuvant chemotherapy, at completion or transition of primary treatment, and six months after treatment ends. Cognitive domains assessed include learning and memory, processing speed, and executive function using the Rey Verbal Learning Test, Trail Making Test, and Controlled Oral Word Association. Routinely collected NCCN distress thermometer results may also be used as a quality-of-life measure.
Who should consider this trial
Good fit: Adults (18+) with suspected or pathologically confirmed advanced epithelial ovarian cancer who plan to receive neoadjuvant platinum/taxane-based chemotherapy, speak English as their primary language, and have no history of diagnosed cognitive impairment or traumatic brain injury are ideal candidates.
Not a fit: People with preexisting dementia or diagnosed cognitive impairment, non–English primary speakers, those receiving excluded targeted therapies, or those not receiving neoadjuvant chemotherapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians identify, monitor, and manage cognitive changes related to preoperative chemotherapy, improving patient counseling and supportive care.
How similar studies have performed: Similar cognitive testing approaches have been used in cancer populations (notably breast cancer) with mixed results, but focused data in neoadjuvant ovarian cancer is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Pathological diagnosis of suspected epithelial ovarian cancer; of note, patients with suspected epithelial ovarian cancer who are pending a pathological diagnosis/biopsy may be enrolled onto the study ahead of their biopsy. If the biopsy result is later inconsistent with epithelial ovarian cancer, they will be removed from the study and replaced * Planned to received neoadjuvant chemotherapy with carboplatin and paclitaxel; alternatives to these agents including abraxane, docetaxel, cisplatin may be used if patients have a chemotherapy reaction or otherwise cannot receive carboplatin and paclitaxel per usual standard of care * Patients may be receiving bevacizumab and may receive PARP inhibitors as a maintenance treatment; those receiving any other targeted therapy will be excluded Exclusion Criteria: * History of diagnosed cognitive impairment, including dementia * History of traumatic brain injury * English is not their primary language * Known hearing or visual impairment not corrected with hearing devices and glasses/contacts * Upper extremity motor impairment that would impact ability to perform the Trail Making Test * Baseline Mini Mental State Exam (MMSE) score less than 18
Where this trial is running
Madison, Wisconsin
- UW Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Barroilhet, MD — UW Carbone Cancer Center
- Study coordinator: Supportive Oncology
- Email: supportiveoncology@uwcarbone.wisc.edu
- Phone: (608)263-6002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.